Clareo Health | Comparison of DTM™ SCS Therapy Combined With Conventional Medical Management (CMM) to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Spine Surgery
Comparison of DTM™ SCS Therapy Combined With Conventional Medical Management (CMM) to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Spine Surgery
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MedtronicNeuro
With
SGX Group
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Be a candidate for SCS system (trial and implant)
You may not be if
Has an average back pain intensity ≥ 6.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment
Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided.
Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand and sign the written inform consent
Be 18 years of age or older at the time of enrollment
Be on a stable pain medication regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study
Be willing and able to comply with study-related requirements, procedures, and visits
Had a previous spinal surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy)
Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available Intellis™ SCS systems as determined by the Investigator
Has a diagnosed back condition with inflammatory causes of back pain (e.g., onset of severe pain with activity), serious spinal pathology and/or neurological disorders as determined by the Investigator
Be concurrently participating in another clinical study
Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump, etc.
Has pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator
Has mechanical spine instability as determined by the Investigator
Has undergone, within 30 days prior to enrollment, an interventional procedure and/or surgery to treat back and/or leg pain, which is providing significant pain relief
Has unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the investigator
Be involved in an injury claim under current litigation or has a pending or approved worker's compensation claim
Be pregnant (determined by urine testing unless female subject is surgically sterile or post-menopausal. If female, sexually active, and childbearing age, subject must be willing to use a reliable form of birth control.)
